NCT00769496

Brief Summary

A long-term study of BAY77-1931 (lanthanum carbonate) for hyperphosphatemia in patients undergoing hemodialysis

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
145

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jan 2005

Typical duration for phase_2

Geographic Reach
1 country

14 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 8, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 9, 2008

Completed
Last Updated

January 23, 2013

Status Verified

January 1, 2013

Enrollment Period

3.3 years

First QC Date

October 8, 2008

Last Update Submit

January 21, 2013

Conditions

Hyperphosphatemia

Outcome Measures

Primary Outcomes (1)

  • Changes in pre-dialysis serum phosphate levels

    Every 4 weeks

Secondary Outcomes (5)

  • Achievement rate of the target predialysis serum phosphate levels (3.5 mg/dL and 5.5 mg/dL)

    Every 4 weeks

  • Changes in corrected serum calcium level

    Every 4 weeks

  • Changes in the product of serum calcium and phosphate

    Every 4 weeks

  • Changes in serum intact-PHT levels

    Every 4 weeks

  • Changes in bone metabolism markers

    Every 4 weeks

Study Arms (1)

Arm 1

EXPERIMENTAL
Drug: BAY 77-1931

Interventions

BAY 77-1931DRUG

Lanthanum Carbonate (BAY 77-1931)

Arm 1

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Undergoing hemodialysis 3 times per week for chronic renal failure for the previous 3 consecutive months at least

You may not qualify if:

  • Pre-dialysis serum phosphate levels of 10.0mg/dL during the washout period

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Unknown Facility

Toyohashi, Aichi-ken, 441-8023, Japan

Location

Unknown Facility

Yatomi, Aichi-ken, 498-0006, Japan

Location

Unknown Facility

Chiba, Chiba, 261-0011, Japan

Location

Unknown Facility

Kashiwa, Chiba, 277-0084, Japan

Location

Unknown Facility

Narita, Chiba, 286-0041, Japan

Location

Unknown Facility

Sakura, Chiba, 285-0846, Japan

Location

Unknown Facility

Hiroshima, Hiroshima, 730-0811, Japan

Location

Unknown Facility

Asahikawa, Hokkaido, 070-0030, Japan

Location

Unknown Facility

Kochi, Kochi, 780-0066, Japan

Location

Unknown Facility

Kochi, Kochi, 780-8040, Japan

Location

Unknown Facility

Kochi, Kochi, 781-5103, Japan

Location

Unknown Facility

Okayama, Okayama-ken, 701-0202, Japan

Location

Unknown Facility

Suita, Osaka, 564-0053, Japan

Location

Unknown Facility

Tokushima, Tokushima, 770-0011, Japan

Location

MeSH Terms

Conditions

Hyperphosphatemia

Condition Hierarchy (Ancestors)

Phosphorus Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 8, 2008

First Posted

October 9, 2008

Study Start

January 1, 2005

Primary Completion

May 1, 2008

Study Completion

May 1, 2008

Last Updated

January 23, 2013

Record last verified: 2013-01

Locations

JP(14)